NCT06282055 Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
| NCT ID | NCT06282055 |
| Status | Recruiting |
| Phase | — |
| Sponsor | DCB Research AG |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2025-11-20 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.
Eligibility Criteria
Inclusion criteria: * Female sex * Between 18 and 40 years at inclusion * Menarche at least one year prior to study inclusion * Regular menstrual cycle (at least one menstrual cycle in the last 40 days) * Average menstrual cycle length between 21 and 38 days * Difference in length between consecutive menstrual cycles of at most 7 days * Living with type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year * Actively using an AID system for their diabetes management at least six months prior to study inclusion Exclusion criteria: * Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception * Pregnancy until two months postpartum (ongoing or planned) * Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping * Known Polycystic Ovary Syndrome (PCOS) * Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs * Individuals with work patterns involving frequent shifts between night and day work (e.g., alternating night and day shifts on a weekly or similar basis). * Participation in an interventional study within two months preceding and during the present study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06282055 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06282055 currently recruiting?
Yes, NCT06282055 is actively recruiting participants. Contact the research team at stefanie.hossmann@dcberne.com for enrollment information.
Where is the NCT06282055 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06282055 clinical trial?
NCT06282055 is sponsored by DCB Research AG. The trial plans to enroll 350 participants.
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